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Trial record 5 of 72 for:    Talc

Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis

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ClinicalTrials.gov Identifier: NCT02825095
Recruitment Status : Unknown
Verified July 2016 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
Prospective study of the effect of Talc Pleurodesis vs. Indwelling Pleural catheter in treatment of patients with malignant pleural effusion

Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Lung Neoplasms Procedure: Talc Pleurodesis Procedure: Indwelling Pleural Catheter Procedure: chest ultrasound Drug: Local anesthesia Procedure: Chest Tube Early Phase 1

Detailed Description:

Randomized prospective study that will include 120 patients with malignant pleural effusion with high rate of accumulation; less than one month, The patients will be divided randomly for two groups, each group 60 patients, the first group will undergoes talc pleurodesis, the second group will undergoes Indwelling Pleural catheter insertion.

The two groups will be followed up for one year, starting at the time of intervention, after 14 days of intervention, after 30 days of intervention, once monthly for one year.

The patients will be evaluated according to the rate of complication; need for further intervention in each group, improvement of the quality of life, respiratory improvement, radiological evaluation based on chest Xray findings, rate and duration of admissions that are related to pleural effusion during the year of study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Malignant Pleural Effusion - Indwelling Pleural Catheter or Talc Pleurodesis ; a Prospective Randomized Controlled Study.
Study Start Date : August 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Talc Pleurodesis

For patients in this group, chest tube type PIGTAIL 10 - 14 Fr will be inserted by by chest ultrasound guided and under local anesthesia, allowing good draining of the hemithorax, in case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed, chest tube will be removed 24 - 48 hours later on. the patient will be admitted in the hospital during the whole procedure course.

If the patient developed non expanded - trapped lung post chest tube insertion, or if he had persistence high chest tube output for more than 10 days, then the patient will remain with the PIGTAIL as an Indwelling Pleural Catheter.

Procedure: Talc Pleurodesis
chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed

Procedure: chest ultrasound
All insertion of a chest drain will be guided by ultrasound

Drug: Local anesthesia
Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
Other Names:
  • Lidocaine hydrochloride
  • Esracain injection 2%

Procedure: Chest Tube
chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed
Other Name: PIGTAIL

Active Comparator: Indwelling Pleural Catheter

All patients from this group will have Indwelling Pleural Catheter insertion type PLEURAX inserted by ultrasound guided and under local anesthesia.

the patient and his/her family will be instructed and educated about the proper way of using the catheter, and how to perform pleural draining at home.

the duration of treatment with the Pleurax depends on the rate and amount of pleural effusion draining.

Procedure: Indwelling Pleural Catheter
Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.

Procedure: chest ultrasound
All insertion of a chest drain will be guided by ultrasound

Drug: Local anesthesia
Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
Other Names:
  • Lidocaine hydrochloride
  • Esracain injection 2%




Primary Outcome Measures :
  1. change in Quality of Life [ Time Frame: one year of regular follow up. ]
    the patients will be followed up 14 days post intervention, 30 days, once monthly for 12 months, the patient will fill questioner every month evaluating the quality of life, the daily activities and the degree of shortness of breath.


Secondary Outcome Measures :
  1. procedure and admissions [ Time Frame: one year ]
    The patients will be evaluated for the number of admissions: e.g: how many times he/she was admitted to the hospital, duration of admissions; how many days he was admitted in the hospital each time and procedure related to pleural effusion; types and number of procedures



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with recurrent symptomatic pleural effusion, the diagnosis was obtained by : - positive cytology for malignant cells in the fluid.

    • patients well known for malignancy, with exudative pleural effusion with no alternative diagnosis.
    • pleural biopsy - surgically obtained - with diagnosis of pleural malignancy
    • microscopic intraoperative findings suggestive of pleural malignancy.
  2. Patients who underwent prior to involvement in the study, draining of the pleural fluid with symptomatic improvement.
  3. Patients with rate of fluid accumulation less than 30 days.
  4. Patient who signed informed consent about being involved in the study.

Exclusion Criteria:

  1. Patients under the age of 18 years.
  2. Female patients who are Pregnant or nursing.
  3. Patients with rate of pleural effusion accumulation is more than 30 days.
  4. Patients who didn't show clinical improvement post proper draining of the fluid
  5. Patients who are hemodynamically or respiratory unstable.
  6. Patients with Empyema.
  7. Patients who are non functioning/ not active according to the Performance status.
  8. The type of malignancy which cause the malignant pleural effusion is Lymphoma.
  9. Patient who underwent pneumonectomy at the side of the fluid.
  10. previous pleurodesis at the side of pleural effusion.
  11. Chylothorax in the initial pleural tapping.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825095


Contacts
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Contact: Ran Kremer, MD 00972502063189 r_kremer@rambam.health.gov.il
Contact: Amit Katz, MD 00972502062291 amit160275@gmail.com

Sponsors and Collaborators
Rambam Health Care Campus

Publications:

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02825095     History of Changes
Other Study ID Numbers: 0371-15rmb
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Rambam Health Care Campus:
malignant pleural effusion,talc pleurodesis,quality of life
Additional relevant MeSH terms:
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Lung Neoplasms
Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Pleural Neoplasms
Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action